Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined probiotic and vitamin D supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
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Design
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Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
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Settings and conduct
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Among diabetic patients and CHD referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes patients with coronary heart disease will be included in this study. Exclusion criteria: Exclusion criteria: Taking vitamin D, probiotic and/or synbiotic within the last 3 months, and patients with thyroid disorders.
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Intervention groups
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Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally. Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017073033941N4
Registration date:
2017-08-28, 1396/06/06
Registration timing:
registered_while_recruiting
Last update:
2019-09-20, 1398/06/29
Update count:
1
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Registration date
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2017-08-28, 1396/06/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-08-17, 1396/05/26
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Expected recruitment end date
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2017-08-29, 1396/06/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of combined probiotic and vitamin D supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
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Public title
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Effect of combined probiotic and vitamin D supplementation in treatment of coronary heart disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Subjects aged 45-85 years
Diagnosed with type 2 diabetes and CHD
Exclusion criteria:
Taking vitamin D, probiotic and/or synbiotic within the last 3 months
Patients with thyroid disorders
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Age
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From 45 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-16, 1396/05/25
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.36
Health conditions studied
1
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Description of health condition studied
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Coronary Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic ischaemic heart disease, unspecified
Primary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
5
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Beck Depression Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
10
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Description
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Systolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
11
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Description
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Diastolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
12
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Description
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Beck Anxiety Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
13
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Description
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General Health Questionnaire
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and vitamin D supplements (Zahravi, Tabriz, Iran), 50,000 IU vitamin D every 2 weeks, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Probiotic and vitamin D placebo capsules (Barij essence, Kashan, Iran), probiotic placebo daily and vitamin D placebo every 2 weeks, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available